Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects

Launched by ANTABIO · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well a combination of two drugs, ANT3310 and meropenem, works in people with kidney problems, including those with severe kidney disease. The researchers want to understand how these medications are processed in the body and how safe they are for individuals who have different levels of kidney function compared to those with normal kidney function. This trial is currently looking for volunteers aged 18 to 80 who either have impaired kidney function or are healthy with normal kidney function.

Participants in the study will receive an intravenous (i.v.) dose of the medications and will be monitored for their safety and how their bodies respond to the treatment. To be eligible, individuals with kidney issues should have a specific measure of kidney function, while those with normal function should meet certain criteria as well. It's important to note that people with certain medical histories or conditions may not be able to participate. Overall, participants can expect close monitoring and support from the research team throughout the trial.

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Eligibility criteria

• Main Inclusion Criteria:
• • Participant must be 18 to 80 years of age (both inclusive) at the time of signing the informed consent.
• • BMI within the range of 18.0 to 36.0 kg/m2 (both inclusive) with a body weight ≥ 50 kg.
• • Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• • Capable of giving signed informed consent in compliance with the requirements and restrictions listed in the ICF and in the protocol.
• • Ability to cooperate with the investigator and to comply with the requirements of the trial.
• • Sufficient venous access for i.v. infusion and PK samplings.
• • For participants with renal function impairment: Individualized eGFR \<90 mL/min at screening, estimated according to the individualized CKD-EPI equation and stable renal function.
• • For participants with ESRD requiring dialysis: Chronic intermittent hemodialysis for ≥3 months prior to dosing.
• • For participants with normal renal function: Individualized eGFR ≥90 mL/min at screening, estimated based on serum creatinine measured within 10 days prior to Day -1 according to the CKD-EPI equation.
• Main Exclusion Criteria:
• • Febrile illness within 1 week before admission to the study center.
• • Known hypersensitivity to meropenem and or ANT3310 or any of the excipients of the infusion solution.
• • Known severe allergies, non-allergic drug reactions, or multiple drug allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction.
• • Medical disorder, condition, or history of such that would - in the opinion of the investigator - compromise the participant's ability to participate in this study.
• • History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders.
• • Known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to β-lactam antibiotics (e.g., penicillin, cephalosporin, carbapenem, or monobactam).
• • History of Gilbert syndrome.
• • History of any severe antibiotic-associated superinfections like Clostridium difficile colitis and/or frequent fungal vaginal infections.
• • Therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before study drug administration.
• • Positive results for HBsAg, anti-HCV, HIV antibodies (anti-HIV 1+2).
• • For participants with impaired renal function: Acute renal failure or active renal infections, Clinically significant impaired hepatic function, Severe infection or any clinically significant illness within 4 weeks before dosing, Impairment of any other major organ system other than the kidney except underlying disease, Diagnosed malignancy during the past 5 years except completely resected basal cell cancer of the skin, Any kidney transplant during the last 10 years, any other organ transplant during the past 5 years.